About this role
Specialist Quality Assurance
What you will do
Responsible for assigned Quality Management Systems (Deviation/CAPA). A Subject Matter Expert (SME) and site representative for Amgen Singapore Manufacturing in Amgen Network for the specified Quality Management System. In case of any system update, new system rollout act as the site project lead.
Responsibilities
- Manages the implementation of process changes and ensures consistent execution of the applicable quality processes in the site
- Purposefully monitors execution of the specified quality processes and communicates performance to Global Process Owners/Users & Management
- Understands process changes and communicates impact to management/users
- Attends network/collaboration group meetings and represents site/functional challenges, lessons learned, audit and inspection findings and best practices
- Reviews applicable Global Standard, and may author or QA process documentation or training materials
- On-boards new users; provides training, facilitates learning groups and is a coach/mentor to users
- Escalates performance issues and trends to the Global Process Owners, site management reviews, applicable SMEs and site/functional/regional management
- Ensures inspection readiness and applicable local procedures are in alignment with quality process requirements and QMS architecture
- Represents process during audits and regulatory agency inspections.
- Engages with GPO when commitments are made after regulatory inspections
- Develops and owns site/region specific commitments for process
- Participates in process improvements initiated by the GPO/Network
- May lead process improvements projects across the site/function/region.
- May own site /function Deviations, CAPA/EVs, and change records for process
- QA contact for site /function Deviations, CAPA/EVs and change control records
- All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and